Inspections, Compliance, Enforcement, and Criminal Investigations
Excel Medical Products, Inc. 4/9/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, Ml 48207
April 9, 2013
Mr. Adam J. Cole
President and CEO
Excel Medical Products, Inc.
3145 Copper Avenue
Fenton, MI 48430
Dear Mr. Cole:
During an inspection of your firm located in Fenton, Michigan on November 19, 2012 through December 21, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of Class II Hemostatic Y-connectors. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act 21, U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your response dated January 14, 2013 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example,
- The injection molding process for clear 6 Fr. cap and rotator components using the (b)(4) injection molder has not been validated. The Performance Qualification Plans and Reports were not available for the (b)(4).
- The injection molding process for the 6 Fr. (purple), 8 Fr. (clear), and 7, 9, and 10 Fr. (both clear and purple) Y-body components have not been validated. As specified by the routers, the injection molding parameter setting used in production of Y-body components vary by component size and color.
- The injection molding process for clear 6 Fr. Y-body components has not been validated for all of the operating parameters used during production.
The adequacy of your firm’s response cannot be determined at this time. You have indicated an updated validation will be performed for all Y-body components, and will include all sizes and material color variations sold by Excel Medical. These are planned actions that we cannot evaluate at this time.
2. Failure to establish and maintain a design history file (DHF) for each type of device, which, shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan, as required by 21 CFR 820.30(j). For example, design history files have not been established for sizes 4.5, 7, and 10 Fr. Hemostatic Y-connector devices.
The adequacy of your firm’s response cannot be determined at this time. You indicate an updated process validation will be performed for all Y-body components and a component qualification. At the completion of the qualification, you will compile design files that represent current design, and include a compilation of the results of the validation, the validation report, and any additional supporting documentation. These are planned actions that we cannot evaluate at this time.
3. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, procedures addressing the documentation and evaluation of nonconforming product resulting from the production set-up have not been established.
The adequacy of your firm’s response cannot be determined at this time. You plan on creating a new setup procedure for each of the Y-body component tools; modifying your reject data collection sheet to document the nonconforming product resulting from production set-up; and a process deviation form will be created. These are planned actions that we cannot evaluate at this time.
4. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). For example, complaints received have not been evaluated for Medical Device Reporting. The procedures, PC-109: Product Incident Reporting, (Revision F, effective 7/28/2011; Revision E, effective 7/22/2003) state that the Product Incident Form (FM-103; Product Incident/MDR Determination Form) will be used for documenting each incident. Of the 12 complaints documented by your firm since 1/2010, seven lacked an associated form, FM-103, as documented evidence that these complaints were evaluated for MDR reportability. This form is the only means of evaluating complaints for MDR reportability.
The adequacy of your firm’s response cannot be determined at this time. You are in the process of creating, and implementing a complaint handling system that operates independently of the CAPA system. These are planned actions that are still in the process of being implemented and we cannot evaluate at this time.
5. Failure to adequately evaluate and select potential suppliers, contractors, and consultants, on the basis of their ability to meet specified requirements, including quality requirements and failure to document this evaluation as required by 21 CFR 820.50(a)(1). For example, your supplier of tooling pins has not been evaluated and selected based on their ability to meet specified requirements. A form FM-368, (Supplier Assessment), has not been completed for this supplier; and the supplier does not appear on the current Approved Supplier List.
The adequacy of your firm’s response cannot be determined at this time. You plan on performing a formal, documented assessment of your supplier of tooling pins in accordance with Excel’s purchasing controls. This is a planned action that we cannot evaluate at this time.
The Hemostatic Y-connector device is also adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency as defined by 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our inspection revealed there have been substantial changes to the Hemostatic Y-connector including, but not limited to, material, design, and size changes since the K884327 was cleared. The original 510(k) description reads as “Disposable Y-Connector with adjustable valve, inside diameter of the smallest portion of the valve is 0.075 in. (5.8F.).” Hemostatic Y-Connector devices have been distributed in 2005, 2009, and 2011 in sizes 10 Fr., 7 Fr., and 4.5 Fr., respectively.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Catherine V. Quinlan, Compliance Officer, Food and Drug Administration at 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about the contents of this letter, please contact Ms. Quinlan at (313)393-8153.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Art O. Czabaniuk
Acting District Director
Detroit District Office